Iron Fortified Beverages and Application in Women Predisposed to Anemia

Sponsors

Lead Sponsor: National Research Council, Spain

Collaborator: Ministry of Science and Innovation, Spain
Grupo Leche Pascual
Madrid Salud, Madrid, Spain

Source National Research Council, Spain
Brief Summary

- The objective of the study is to know if consumption of an iron fortified fruit juice containing micronized iron pyrophosphate, is useful to increase iron status in women predisposed to iron deficiency anemia.

- A secondary objective is to know if consumption of this iron fortified fruit juice modifies bone remodelling.

Overall Status Completed
Start Date November 2008
Completion Date May 2009
Primary Completion Date January 2009
Phase N/A
Study Type Interventional
Primary Outcome
Measure Time Frame
Serum Ferritin monitored during 16 weeks
Secondary Outcome
Measure Time Frame
Serum transferrin monitored during 16 weeks
Hemoglobin monitored during 16 weeks
serum iron monitored during 16 weeks
transferrin saturation monitored during 16 weeks
soluble transferrin receptor monitored during 16 weeks
zinc protoporphyrin monitored during 16 weeks
Total red blood cells monitored during 16 weeks
Hematocrit monitored during 16 weeks
Mean corpuscular volume monitored during 16 weeks
Red blood cell distribution width monitored during 16 weeks
25-hydroxycholecalciferol monitored during 16 weeks
alkaline phosphatase bone-isoenzyme (ALP) monitored during 16 weeks
serum cross-linked N-telopeptide of type I collagen (NTx) monitored during 16 weeks
Total cholesterol monitored during 16 weeks
HDL-cholesterol monitored during 16 weeks
LDL-cholesterol monitored during 16 weeks
Glucose monitored during 16 weeks
Serum triacylglycerols monitored during 16 weeks
T-chol/HDL-chol monitored during 16 weeks
LDL-chol/HDL-chol monitored during 16 weeks
Systolic blood pressure monitored during 16 weeks
Diastolic blood pressure monitored during 16 weeks
Enrollment 122
Condition
Intervention

Intervention Type: Dietary Supplement

Intervention Name: non-fortified fruit juices consumed as part of the usual diet

Arm Group Label: Placebo juices

Intervention Type: Dietary Supplement

Intervention Name: Iron fortified fruit juice

Description: Consumption of micronized iron pyrophosphate supplemented fruit juices as part of the usual diet

Arm Group Label: Iron fortified fruit juices

Eligibility

Criteria:

Inclusion Criteria:

- Women

- non-smoker

- non-pregnant

- non-breastfeeding

- serum ferritin <40 ng/ml

- hemoglobin>=11g/dl

Exclusion Criteria:

- Serum Ferritin >=40 ng/ml

- Hemoglobin <11g/dl

- Amenorrhea

- Menopause

- Iron deficiency anemia

- Thalassemia

- Hemochromatosis

- Blood donors

- Chronic gastric diseases

- Renal diseases

- Eating disorders

- Allergy to any component of the study juices

- Consumption of iron or ascorbic acid supplements within 4 month prior to participating in the study

Gender: Female

Minimum Age: 18 Years

Maximum Age: 35 Years

Healthy Volunteers: Accepts Healthy Volunteers

Verification Date

December 2012

Responsible Party

Type: Principal Investigator

Investigator Affiliation: National Research Council, Spain

Investigator Full Name: M Pilar Vaquero

Investigator Title: Scientific Researcher

Keywords
Has Expanded Access No
Condition Browse
Number Of Arms 2
Arm Group

Label: Placebo juices

Type: Placebo Comparator

Description: Consumption of non-iron fortified fruit juices as part of the usual diet

Label: Iron fortified fruit juices

Type: Experimental

Description: Consumption of iron fortified fruit juices as part of the usual diet

Acronym FeDrink
Study Design Info

Allocation: Randomized

Intervention Model: Parallel Assignment

Primary Purpose: Prevention

Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Source: ClinicalTrials.gov